Effect of Acetazolamide on Sleep Disordered Breathing in Women and Men
HighCycle Study: Effect of Acetazolamide on Sleep Disordered Breathing in Women. A Randomized, Placebo-Controlled, Double-Blind Parallel Trial.
This study is testing if acetazolamide can help healthy men and women aged 18-44 with sleep problems while traveling to high altitudes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Bishkek, Bishkek) |
| Trial ID | NCT06498531 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of acetazolamide on sleep disordered breathing in healthy men and women aged 18-44 years who are traveling to an altitude of 3600 meters. Participants will be randomly assigned to receive either acetazolamide or a placebo. The study aims to compare the effects of the medication between genders, focusing on premenopausal women with regular menstrual cycles. The trial will include individuals who have lived at lower altitudes and are free from significant health issues.
Who should consider this trial
Good fit: Ideal candidates are healthy, non-smoking men and women aged 18-44, living at altitudes below 1000 meters, with a BMI between 18 and 30.
Not a fit: Patients who are pregnant, nursing, or have certain health conditions such as anemia or allergies to acetazolamide will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into gender-specific treatments for sleep disordered breathing, potentially improving patient outcomes.
How similar studies have performed: While studies on acetazolamide have been conducted, this specific focus on gender differences in sleep disordered breathing at high altitude is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy, non-smoking men and women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives). * BMI \>18 kg/m2 and \<30 kg/m2 * Born, raised and currently living at altitudes \<1000 m * Written informed consent * Premenopausal women with an eumenorrheic cycle Exclusion Criteria: * Other types of contraceptvies (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others) * Pregnancy or nursing * Anaemic (haemoglobin concentration \<10g/dl) * Any altitude trip \<4 weks before the study * Allergy to acetazolamide and other sulfonamides
Where this trial is running
Bishkek, Bishkek
- National Center for Cardiology and Internal Medicine — Bishkek, Bishkek, Kyrgyzstan (Recruiting)
Study contacts
- Study coordinator: Michael Furian, Prof. Dr.
- Email: michael.furian@usz.ch
- Phone: +41794037586
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.